Over-eatingNCT01976455
The Breathe Light Study
An observational study of Over-eating and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Over-eating, Obesity
- What is being tested?
- 20% fewer calories and 40% fewer calories
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men \& Women age 18 to 65 years with a BMI of 25- 40 kg/m2.
Who may be able to join
- 18 to 65 years old
- Overweight (BMI 25-40 kg/m2)
Who cannot join
- Metabolic or cardiovascular abnormalities (diabetes, uncontrolled hypertension, etc.)
- Gastrointestinal disorders
- Disease that affects macronutrient utilization
- Medication that affects macronutrient utilization
- Allergies to foods to be utilized in the study (including but not limited to lactose intolerance/milk allergy)
- Use of nutritional/sport supplements
- Pregnant or currently trying to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: The Breathe Light Study: Validation of Carbon Stable Isotope Ratio in Breath as an Indicator of Energy Balance and Substrate Utilization
The purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance.
- Conditions
- Over-eating, Obesity
- Being tested
- 20% fewer calories, 40% fewer calories
- Keywords
- obesity, carbon13, over-eating, metabolic chamber, room calorimeter
- Medical subject headings
- Hyperphagia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% fewer caloriesOther
40% fewer caloriesOther
| Study group | Role | What they receive |
|---|---|---|
| 20% calorie depletion | During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other). Receives: Other: 20% fewer calories; Other: 40% fewer calories | |
| 40% calorie depletion | During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other). Receives: Other: 20% fewer calories; Other: 40% fewer calories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in breath Carbon 13 with overconsumption of calories
A period of positive energy balance following one of negative energy balance increase breath Carbon13.
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over-eatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Other
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shanon Casperson, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research CenterJames N Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976455
- Sponsor's protocol ID
- GFHNRC505
- Status last verified
- Jan 2022
- First submitted
- 12 Sep 2013
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Breathe Light Study: Validation of Carbon Stable Isotope Ratio in Breath as an Indicator of Energy Balance and Substrate Utilization
- ClinicalTrials.gov ID
- NCT01976455
- Acronym / sponsor ID
- GFHNRC505
- Conditions
- Over-eating, Obesity
- Keywords
- obesity, carbon13, over-eating, metabolic chamber, room calorimeter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Oct 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance.
Study design
- Observational model
- Case crossover
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% calorie depletion | – | Other: 20% fewer calories, Other: 40% fewer caloriesDuring each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other). |
| 40% calorie depletion | – | Other: 20% fewer calories, Other: 40% fewer caloriesDuring each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men \& Women age 18 to 65 years with a BMI of 25- 40 kg/m2.
Key inclusion criteria (2 listed)
- 18 to 65 years old
- Overweight (BMI 25-40 kg/m2)
Key exclusion criteria (7 listed)
- Metabolic or cardiovascular abnormalities (diabetes, uncontrolled hypertension, etc.)
- Gastrointestinal disorders
- Disease that affects macronutrient utilization
- Medication that affects macronutrient utilization
- Allergies to foods to be utilized in the study (including but not limited to lactose intolerance/milk allergy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20% fewer calories | Other | 20% calorie depletion, 40% calorie depletion |
| 40% fewer calories | Other | 20% calorie depletion, 40% calorie depletion |
Primary outcome
Increase in breath Carbon 13 with overconsumption of calories
Time frame: 11 days
A period of positive energy balance following one of negative energy balance increase breath Carbon13.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanon Casperson, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
James N Roemmich, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Over-eating and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in breath Carbon 13 with overconsumption of calories (time frame: 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.